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Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

This study is currently recruiting participants.
Verified February 2017 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483249
First Posted: June 6, 2007
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.

Condition Intervention Phase
Thoracoabdominal Aortic Aneurysm Paravisceral Abdominal Aortic Aneurysm Device: Endovascular Branched Stent-Graft Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Successful implantation of TAAA branched stent-graft. [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Long term success of TAAA branched stent-graft treatment. [ Time Frame: 5 years ]

Estimated Enrollment: 250
Study Start Date: May 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).
Device: Endovascular Branched Stent-Graft
Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.

Detailed Description:
A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. The standard operation for TAAA of PVAAA is performed through a long incision extending down the side of the chest and the front of the abdomen. In the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). The combination of a stent and a graft is known as a stent-graft. Compared with standard operation, the potential advantages of endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. The main disadvantage of endovascular TAAA/PVAAA is an unknown success rate.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Aortic aneurysms:

    • greater than or equal to 6 cm in diameter in men,
    • greater than or equal to 5.5 cm in diameter in women,
    • and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year,
    • and/or iliac aneurysms larger than 4 cm in diameter.
  2. Anticipated mortality comparable to published rates with conventional surgical treatment.
  3. Life expectancy more than 2 years.
  4. Ability to give informed consent.
  5. Willingness to comply with follow-up schedule.
  6. Suitable arterial anatomy for endovascular repair.

Exclusion Criteria

  1. Free rupture of the aneurysm.
  2. Pregnancy.
  3. Known allergy to Nitinol, stainless steel, or polyester.
  4. Unwillingness or inability to comply with the follow up schedule.
  5. Serious systemic or groin infection.
  6. Uncorrectable coagulopathy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483249


Contacts
Contact: Linda M Reilly, MD 415 353 4366 linda.reilly2@ucsf.edu
Contact: Warren J Gasper, MD 415 750 2115 warren.gasper@ucsf.edu

Locations
United States, California
Division of Vascular Surgery, SFVAMC Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Warren J Gasper, MD         
Principal Investigator: Linda M Reilly, MD         
Division of Vascular Surgery, UCSF Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Linda M Reilly, MD         
Principal Investigator: Warren J Gasper, MD         
Sub-Investigator: Timothy AM Chuter, MD         
Sub-Investigator: Jade S Hiramoto, MD         
Sub-Investigator: Shant M Vartanian, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Linda M Reilly, MD University of California, San Francisco
  More Information

Publications:
Crawford ES, DeNatale RW. Thoracoabdominal aortic aneurysm: observations regarding the natural course of the disease. J Vasc Surg. 1986 Apr;3(4):578-82.
Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70.
Martin GH, O'Hara PJ, Hertzer NR, Mascha EJ, Krajewski LP, Beven EG, Clair DG, Ouriel K. Surgical repair of aneurysms involving the suprarenal, visceral, and lower thoracic aortic segments: early results and late outcome. J Vasc Surg. 2000 May;31(5):851-62.
Cambria RP, Davison JK, Carter C, Brewster DC, Chang Y, Clark KA, Atamian S. Epidural cooling for spinal cord protection during thoracoabdominal aneurysm repair: A five-year experience. J Vasc Surg. 2000 Jun;31(6):1093-102.
Walker SR, Yusuf SW, Wenham PW, Hopkinson BR. Renal complications following endovascular repair of abdominal aortic aneurysms. J Endovasc Surg. 1998 Nov;5(4):318-22.
Thompson JP, Boyle JR, Thompson MM, Strupish J, Bell PR, Smith G. Cardiovascular and catecholamine responses during endovascular and conventional abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 1999 Apr;17(4):326-33.
Zarins CK, White RA, Schwarten D, Kinney E, Diethrich EB, Hodgson KJ, Fogarty TJ. AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial. J Vasc Surg. 1999 Feb;29(2):292-305; discussion 306-8.
May J, White GH, Yu W, Ly CN, Waugh R, Stephen MS, Arulchelvam M, Harris JP. Concurrent comparison of endoluminal versus open repair in the treatment of abdominal aortic aneurysms: analysis of 303 patients by life table method. J Vasc Surg. 1998 Feb;27(2):213-20; discussion 220-1.
Chuter TA, Reilly LM, Faruqi RM, Kerlan RB, Sawhney R, Canto CJ, LaBerge JM, Wilson MW, Gordon RL, Wall SD, Rapp J, Messina LM. Endovascular aneurysm repair in high-risk patients. J Vasc Surg. 2000 Jan;31(1 Pt 1):122-33.
Mitchell RS, Miller DC, Dake MD, Semba CP, Moore KA, Sakai T. Thoracic aortic aneurysm repair with an endovascular stent graft: the "first generation". Ann Thorac Surg. 1999 Jun;67(6):1971-4; discussion 1979-80.
Kinney EV, Kaebnick HW, Mitchell RA, Jung MT. Repair of mycotic paravisceral aneurysm with a fenestrated stent-graft. J Endovasc Ther. 2000 Jun;7(3):192-7.
Iwase T, Inoue K, Sato M, Yoshida Y, Ueno K, Tanaka H, Tamaki S. Transluminal repair of an infrarenal aortoiliac aneurysm by a combination of bifurcated and branched stent grafts. Catheter Cardiovasc Interv. 1999 Aug;47(4):491-4.
Chuter TA, Gordon RL, Reilly LM, Goodman JD, Messina LM. An endovascular system for thoracoabdominal aortic aneurysm repair. J Endovasc Ther. 2001 Feb;8(1):25-33.
Anderson JL, Berce M, Hartley DE. Endoluminal aortic grafting with renal and superior mesenteric artery incorporation by graft fenestration. J Endovasc Ther. 2001 Feb;8(1):3-15.
Chuter TA, Buck DG, Schneider DB, Reilly LM, Messina LM. Development of a branched stent-graft for endovascular repair of aortic arch aneurysms. J Endovasc Ther. 2003 Oct;10(5):940-5.
Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. Epub 2007 Nov 5.
Chuter TA, Hiramoto JS, Park KH, Reilly LM. The transition from custom-made to standardized multibranched thoracoabdominal aortic stent grafts. J Vasc Surg. 2011 Sep;54(3):660-7; discussion 667-8. doi: 10.1016/j.jvs.2011.03.005. Epub 2011 Jul 23.
Chuter T, Greenberg RK. Standardized off-the-shelf components for multibranched endovascular repair of thoracoabdominal aortic aneurysms. Perspect Vasc Surg Endovasc Ther. 2011 Sep;23(3):195-201. doi: 10.1177/1531003511430397. Review.
Reilly LM, Rapp JH, Grenon SM, Hiramoto JS, Sobel J, Chuter TA. Efficacy and durability of endovascular thoracoabdominal aortic aneurysm repair using the caudally directed cuff technique. J Vasc Surg. 2012 Jul;56(1):53-63; discussion 63-4. doi: 10.1016/j.jvs.2012.01.006. Epub 2012 May 3.
Gasper WJ, Reilly LM, Rapp JH, Grenon SM, Hiramoto JS, Sobel JD, Chuter TA. Assessing the anatomic applicability of the multibranched endovascular repair of thoracoabdominal aortic aneurysm technique. J Vasc Surg. 2013 Jun;57(6):1553-8; discussion 1558. doi: 10.1016/j.jvs.2012.12.021. Epub 2013 Feb 6.
Premprabha D, Sobel J, Pua C, Chong K, Reilly LM, Chuter TA, Hiramoto JS. Visceral branch occlusion following aneurysm repair using multibranched thoracoabdominal stent-grafts. J Endovasc Ther. 2014 Dec;21(6):783-90. doi: 10.1583/14-4807R.1.
Sobel JD, Vartanian SM, Gasper WJ, Hiramoto JS, Chuter TA, Reilly LM. Lower extremity weakness after endovascular aneurysm repair with multibranched thoracoabdominal stent grafts. J Vasc Surg. 2015 Mar;61(3):623-8. doi: 10.1016/j.jvs.2014.10.013. Epub 2014 Nov 25.
Fernandez CC, Sobel JD, Gasper WJ, Vartanian SM, Reilly LM, Chuter TA, Hiramoto JS. Standard off-the-shelf versus custom-made multibranched thoracoabdominal aortic stent grafts. J Vasc Surg. 2016 May;63(5):1208-15. doi: 10.1016/j.jvs.2015.11.035. Epub 2016 Jan 24.
Ramanan B, Fernandez CC, Sobel JD, Gasper WJ, Vartanian SM, Reilly LM, Chuter TA, Hiramoto JS. Low-profile versus standard-profile multibranched thoracoabdominal aortic stent grafts. J Vasc Surg. 2016 Jul;64(1):39-45. doi: 10.1016/j.jvs.2016.01.038. Epub 2016 Mar 22.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00483249     History of Changes
Other Study ID Numbers: 10-02810
First Submitted: June 5, 2007
First Posted: June 6, 2007
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by University of California, San Francisco:
Thoracoabdominal
Paravisceral
Aneurysm
Endovascular
Stent-Graft
Aorta

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases


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